Recognizing that the need for effective cybersecurity to ensure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information, the FDA has issued a draft guidance providing recommendations to consider and document in medical device premarket submissions.

A team of researchers from Rice University, Houston, TX, and The Methodist Hospital Research Institute say that submicroscopic particles containing even smaller particles of iron oxide could make magnetic resonance imaging (MRI) a far more powerful tool to detect and fight disease. They created composite particles that can be injected into patients, and then guided by magnetic fields. Once in position, the particles may be heated to kill malignant tissues or trigger the release of drugs at the site and then degrade and leave the body, they said.

A team of researchers from Boston University and Massachusetts General Hospital report their study results in a paper published in the New England Journal of Medicine, that reveals that the latest version of a bionic pancreas device was successfully tested in type 1 diabetics in two five-day clinical trials, one in adults, the other in adolescents. They say that the device imposed minimal restrictions on patient activities, and controlled blood sugar in patients using doses of both insulin and the blood sugar-raising hormone glucagon.

Researchers with the U.S. Department of Energy (DOE)’s Lawrence Berkeley National Laboratory, Berkeley, CA, say that they have demonstrated a technique for producing, detecting, and controlling ultrahigh frequency sound waves at the nanometer scale. Through a combination of subpicosecond laser pulses and unique nanostructures, the team produced acoustic phonons (quasi-particles of vibrational energy that move through an atomic lattice as sound waves) at a frequency of 10 gigahertz. In comparison, medical ultrasounds typically reach a frequency of only about 20 megahertz.

A team of biomedical engineering students at Johns Hopkins University, Baltimore, MD, designed a lightweight, easy-to-conceal shirt-like garment to deliver life-saving shocks to patients experiencing serious heart problems. The students say their design improves upon a wearable defibrillator system that is already in use.

A team of engineers at Brown University, Providence, RI, say that they have developed a new biochip sensor that that can selectively measure glucose concentrations in a complex fluid like saliva. This an important step toward a device that could enable diabetics to test their glucose levels without drawing blood.

A team of engineers at The University of Texas at Austin say that they have built the smallest, fastest, and longest-running synthetic motor to date. This nanomotor, which could fit inside a human cell, is an important step toward developing miniature machines that could one day move through the body to administer insulin for diabetics as needed, or target and treat cancer cells without harming good cells.

Augmented reality is quickly becoming more integrated into everyday usage, such as smartphone apps that can identify landmarks, constellations, and more. Head-worn goggles, like Google Glass can superimpose computer-generated images onto your direct view of the physical world. But, moving your eyes back and forth between a 2D image on the screen and a 3D world in front of you can cause eye strain, particularly for short distances viewing. To combat this, a new device being developed by scientists at the University of Arizona, Tucson, and the University of Connecticut, Storrs, is minimizing this visual discomfort by superimposing 3D images instead of 2D onto views of the real world.

A team of engineers from the University of Illinois at Urbana-Champaign and Northwestern University, Evanston, IL, developed stick-on patches that incorporate off-the-shelf chip-based electronics that can support wireless health monitoring. The patches adhere like a temporary tattoo and incorporate a microfluidic construction with wires folded to allow the patch to bend and flex without being constrained by the rigid electronics components.

Researchers at North Carolina State University, Raleigh, say they have developed a new, stretchable antenna that can be incorporated into wearable health monitoring devices. The team focused on developing an antenna that could be stretched, rolled, or twisted, and easily return to its original shape.

MDB - INSIDE STORY

Christopher Scott

To find out more about the expertise that Eurofins brings to this area, and the company's plans for expansion into the United States, Medical Device Briefs recently spoke with Christopher Scott, vice president of Eurofins Medical Device Testing.